Director, Clinical Operations
Responsibilities of the Director, Clinical Operations:
- Oversee operational strategy for Phase I and II clinical trials within designated program budgets and timelines.
- Responsible for all operational aspects and progress of clinical trial from study planning, to execution including tracking all applicable performance metrics and quality indicators within GCP compliance.
- Manage third party CRO/vendors including timelines, data, samples, and budgets.
- Responsible for vendor budget activities, investigator payments, clinical trial agreements.
- Help develop and review SOPs, Protocols, Clinical Study Reports, INDs, NDAs, and other clinical, regulatory/safety documents.
- Provides oversight for quality assurance and monitor for compliance to GCP and relevant regulations.
Requirements of the Director, Clinical Operations:
- BS/MS/Ph.D in life science related discipline with 4+ years’ experience managing clinical trials.
- Experience managing clinical CRO strongly preferred.
- Must have experience in pharmaceuticals with biologics or small molecule therapeutics, ideally in oncology.
- Working knowledge of ICH, GCP, and FDA guidelines and regulations is required.
- Experience in early phase and discovery preferred.
Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.